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The rising impact of biomarkers in early clinical development

Drug Target Review

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. International Journal of Molecular Sciences. Silver Spring (MD): Food and Drug Administration (US); 2016-. 21(10):3517.

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Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

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Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Alta Sciences

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. WHY IS PAIN RESEARCH SO IMPORTANT? WHAT IS PAIN AWARENESS MONTH? in 2001.

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Phase III study shows Roche’s Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care

The Pharma Data

POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level.

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What Does a CRO Actually Do?

Vial

These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians.

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4 Unique Challenges of Oncology Trials

Advarra

Enrollment barriers may affect: Protocol/design factors Oncology clinical trials often have complex trial design due to their advanced precision medicine treatments. Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements. This means study startup times can vary greatly.

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Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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